The Lean Machine Software Validation

The Lean Machine (Lean & Mean Business Systems, Inc.) database is a comprehensive integrated Quality System that incorporates electronic record keeping and electronic signatures.

The database has been independently validated by C2C Development, LLC to ensure it meets the specific requirements of the following standards:

21 CFR Part 820 - Quality System Regulation
21 CFR Part 11 - Electronic Records / Electronic Signatures
ISO 13485: 2003 - Medical Devices - Quality management system - Requirements for regulatory purposes.

The validation package includes:

Software Requirements Specification Document (pdf)
Software Requirements Verification (pdf)
FMEA for the Lean Machine (excel spreadsheet)
Validation Test Protocol (pdf)
Validation Report (pdf)
Part 11 Checklist (pdf)

Detail Work Instructions for all modules are also available.

Please contact Craig Pagan (321) 728-0125 Ext 100 for information regarding the validation package and detailed work instructions.